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Herbert Bone Screw

by Zimmer, Inc.

510(k) K792022

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK792022 Date26 Oct 1979ClearedStatusActive

Recalls

6 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1038-2014 FDA Class II initiated 11 Oct 2013
    • Terminated Z-1002-2014 FDA Class II initiated 11 Oct 2013

    Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.

  • 4 recalls, same reason

    • Terminated Z-1349-06 FDA Unclassified (pre-2012) initiated 26 Jun 2006
    • Terminated Z-1351-06 FDA Unclassified (pre-2012) initiated 26 Jun 2006
    • Terminated Z-1348-06 FDA Unclassified (pre-2012) initiated 26 Jun 2006
    • Terminated Z-1350-06 FDA Unclassified (pre-2012) initiated 26 Jun 2006

    Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HWC
Device class
Class II
Regulation
21 CFR Part 888.3040
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Herbert Bone Screw is a headless, cannulated orthopedic screw designed for internal fixation of small bone fragments. It features a variable pitch thread and a compact profile, allowing for precise placement through articular cartilage and beneath the bone surface to avoid soft tissue interference. This device is specifically engineered for applications requiring minimal disruption to joint articulation, such as scaphoid pseudarthrosis repair.

The Herbert Bone Screw is supplied as part of the Zimmer Herbert/Whipple Orthopedic Bone Screw System, which includes components like alignment guides, cannulas, and guide wires. It is intended for single-use in sterile surgical environments and must be handled according to aseptic techniques. The device is classified under product code HWC and has been cleared by the FDA via a Traditional 510(k) pathway (K792022). No additional regulatory markings or sterility assurances are specified beyond the stated clearance.

Other devices from Zimmer, Inc.

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Questions

AI-generated answers, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of bone repairs is the Herbert Bone Screw specifically designed for, and why is its design important in those cases?

    The Herbert Bone Screw is designed for internal fixation of small bone fragments, particularly in delicate joint repairs like scaphoid pseudarthrosis. Its headless, cannulated design and compact profile allow for precise placement beneath the bone surface without disrupting soft tissue or joint articulation, making it ideal for minimally invasive procedures where preserving joint function is critical.

  • Is the Herbert Bone Screw meant to be reused in surgery, or is it intended for single-use only? How should it be handled to maintain sterility?

    The Herbert Bone Screw is explicitly intended for single-use in sterile surgical environments. Since it is part of the Zimmer Herbert/Whipple Orthopedic Bone Screw System, it must be handled using aseptic techniques to prevent contamination, as reuse is not recommended or supported by the manufacturer.

  • What other tools or components are included in the Zimmer Herbert/Whipple Orthopedic Bone Screw System, and how do they complement the Herbert Bone Screw?

    The system includes alignment guides, cannulas, and guide wires, which work together to facilitate precise screw placement. The cannulated design of the screw allows for guided insertion using these tools, reducing the risk of misalignment and improving accuracy—especially in complex repairs like scaphoid fractures where minimal disruption is essential.

  • How was the Herbert Bone Screw’s regulatory pathway determined, and what does the product code (HWC) indicate about its classification?

    The Herbert Bone Screw was cleared via the FDA’s Traditional 510(k) pathway (K792022), with a decision of *Substantially Equivalent* (SESE) by the Orthopedic (OR) Advisory Committee. The product code HWC classifies it under orthopedic hardware for internal fixation, confirming its use in surgical bone stabilization procedures.